Thermo Scientific Integrated Informatics Solutions for the ...€¦ · 2 Thermo Scientific Integrated Informatics Solutions for the Food & Beverage Industry Food safety is a global

Thermo Scientific Integrated Informatics Solutions for the Food & Beverage Industry

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Thermo Scientific Integrated Informatics Solutions for the Food & Beverage Industry www.thermoscientific.com/SM11

Food safety is a global concern. Thermo Scientific Integrated Informatics Solutions enable food producers around the world to standardize and harmonize operations at all stages of food production, from the farm to the table and from the production of raw ingredients to the packaging that delivers the product to the customer. Our Informatics solutions can help laboratories achieve full compliance with even the strictest regulatory requirements. With the emphasis on improving food safety regulations in the US, Europe and around the world, traceability through all stages of production, processing and distribution is critical for food producers in their efforts to monitor quality, effectively manage recalls and limit product and revenue loss.

A Thermo Scientific Laboratory Information Management System (LIMS) offers a secure environment for the management of batch relationships between raw ingredients, processed materials and packaged goods and can help food producers minimize the risks associated with contaminated foods, ensuring the safety of the consuming public and continuous value to the company’s shareholders.

This eBook has been developed to give you a comprehensive resource when searching for the data management solutions that can help your business meet the challenges of ever-increasing regulatory requirements, as well as product quality and pressures to improve production efficiencies.

We’re ready to help your company meet all your data management challenges.

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Data-Driven Food Safety Monitoring Eases Regulatory Compliance and Delivers Opportunities

Automating Compliance Data ManagementFSMA Section 103, entitled “Hazard Analysis and Risk-Based Preventive Controls,” outlines the structure of a “pre-ventive controls plan” based on the HACCP methodology.

The main challenge of implementing these controls is dealing with the incredible volume of data they produce. A comprehensive HACCP program produces thousands of data points each day, and this data is only as useful as the system that manages them. One of the best solutions for managing this flow of data is a Laboratory Information Management System, or LIMS.

A LIMS collects and manages data over a food product’s entire lifecycle––from incoming ingredient shipments to finished product deliveries and all HACCP points in between. The LIMS helps food producers establish a new HACCP program or strengthen an existing one by guiding them through five critical steps: evaluating hazards, defining preventive steps, establishing monitoring controls, maintaining monitoring records and specifying corrective actions.

Government regulations often seem like a burden to the industry as they typically come with new and some-times challenging reporting requirements. But new regulations also present opportunities because they help to establish clear benchmarks for accountability that can promote higher quality. In industries where regulation is

pervasive––such as the food industry––the most successful companies are typically those that develop systems and practices that maximize these opportunities for process improvement, higher quality and ultimately greater insight into the data capture necessary for regulatory reporting and control over finished product.

Governments worldwide hold their food industries to a higher standard, and rightly so. Even small errors in food production can do serious damage to public health and consumer confidence. Numerous rules exist to enforce quality and safety, from voluntary standards such as ISO 22000 to mandatory regulations such as the U.S. Food Safety Modernization Act (FSMA) or the European Union Regulation (EC) No. 178/2002. Additional regulations exist for specific food and food production processes, such as the Federal Meat Inspection Act or the Egg Products Inspection Act. Most of these regulations are based on trusted quality assurance and quality control paradigms such as the Hazard Analysis and Critical Control Points (HACCP) methodology, which has been widely used in food production for several decades.

Managing this myriad of regulations and standards is hard work, but food producers that take a systematic and software-driven approach to achieving compliance with them can actually make all these rules work in their favor.

By Trish Meek, Thermo Fisher Scientific

As seen in Food Safety Magazine


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Hazard EvaluationEvery food production process is different, so the first step in any compliance program is always identifying the unique HACCP points in a given facility. Food safety and food contamination risks most commonly occur where raw materials are introduced, vessels are opened, product is extracted, materials are added or finished products are packaged. Especially dangerous are the HACCP points that involve employee interaction––and by extension, the potential for human error.

Figure 1 shows a virtual facility map generated by a LIMS which lays out all hazard points within the production plant. Supplier data and outgoing shipments can also be mapped, allowing the facility to organize data by supplier, batch date, outgoing shipment or any other criteria. This capability makes it much easier to identify and manage the effects of process errors.

Defining Preventive StepsNowhere is the classic adage “an ounce of prevention is worth a pound of cure” truer than in the food production industry. Though a comprehensive HACCP program may be expensive, its cost pales in comparison to the costs of a wide-ranging product recall.

Improper instrument maintenance is one of the most common causes of food production errors. A LIMS can help food producers prevent these errors by providing staff with automated maintenance reminders. The system can also keep track of operator competency records, which allows both management and external auditors to ensure that all staff have received the appropriate training. Lastly, the LIMS can monitor the quality of raw and processed materials as they move through the production facility, iden-tifying out of specification materials at the earliest HACCP point possible.

Figure 1

“ an ounce of prevention is worth a pound of cure”


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Establishing Monitoring ControlsIdentifying hazard points and defining preventive steps represent only the initial planning phase of the compli-ance process. The bulk of the work occurs once monitor-ing actually begins. Fortunately, a LIMS that catalogues all hazard points and preventive steps enables food safety professionals to simplify monitoring by scheduling measurements, setting alerts, applying control limits and analyzing data for each one of a facility’s HACCP points.

All data generated by process monitoring instruments installed at HACCP points are stored in a relational database built into the LIMS. This makes it easy to present information in whatever way is most useful for the intended audience(s). Options include graphs, process map overlays, real-time alerts and more (Figure 3). Control points can also be organized into groups, enabling users to further segment the data and establish consistent sampling plans for each subset.

Maintaining Monitoring RecordsHACCP monitoring data are only as good as the system that manages them. Data lose most of its value if it’s not organized into clear, comprehensive and easily under-standable records. A LIMS simplifies record keeping and retrieval processes by enabling completely paperless data collection and reporting. Networking the LIMS with all HACCP monitoring instruments virtually eliminates manual data collection as well as the enormous potential for human error that manual work creates.

All records stored within the LIMS can be searched and organized according to many variables––including elec-tronic signatures, origin and batch––making both internal and external audits much easier.

Specifying Corrective ActionsA food production facility’s error response time is often the difference between a controlled food safety incident and one that spirals out of control. A LIMS can signifi-cantly reduce a facility’s response time by storing clearly defined corrective actions for every potential incident. When and if an incident occurs, the LIMS can provide automated standard operating procedures that walk staff through the actions necessary to contain and resolve the problem.

After the incident is contained, records stored in the LIMS can be used to determine the potential extent of the damage caused by the incident. This allows management to make more informed decisions about next steps, up to and including recalls. Once the incident has been fully resolved, detailed incident reports are stored within the LIMS for review by both internal and external parties (Figure 4).

ConclusionSolid data management systems are the catalysts that transform food safety regulations from burdens into opportunities. By handling as much of the facility monitoring, data collection and compliance reporting processes as possible, a LIMS allows food safety professionals to cut out much of the most time-consum-ing, error-prone and least value-added work as possible. By focusing on the beneficial consequences of meeting industry regulation, LIMS enables increased process efficiency and helps avoid product safety incidents alto-gether or minimizes the impact if any recalls do occur. •Colin Thurston is a project director at Thermo Fisher Scientific.Figure 4

Figure 3


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Informatics Delivers Traceability and Data Management for Food Safety Monitoring

Food production is a highly regulated industry and for good reason: our system is based on trust. But while food regulations serve an important purpose, they do present significant challenges for the businesses that must comply with them.

Most food producers are subject to a broad range of regulations and standards, from industry-wide ones, such as ISO 22000 (which sets out several communications and system management guidelines), the 2011 United States Food Safety Modernization Act (FSMA) and the European Union Regulation (EC) No. 178/2002, to process-specific ones like the Egg Products Inspection Act (EPIA) or the Federal Meat Inspection Act (FMIA). Most of the industry-wide regulations require extensive application of the Hazard Analysis and Critical Control Points (HACCP) methodology, a systematic approach to preventing food safety hazards that has been in use for several decades.

Ensuring compliance Establishing a ‘preventive controls plan’ (as described in FSMA Section 103 – Hazard Analysis and Risk-Based Preventive Controls) based on the HACCP methodology is the best and simplest way to achieve enterprise-wide compliance. This route is not with-out its challenges, however HACCP, when properly practiced, generates a significant amount of instrument data and records.

Managing this information is key to success, which is why many food producers put a Laboratory Information Management System (LIMS) at the core of their regulatory compliance system. A LIMS enables producers to monitor and record the progress of all product batches as they enter into, travel through and are shipped from production facilities. In addition, it also guides producers through the five steps for establishing a preventive controls plan: evaluating the hazards, specifying preventive steps, specifying how the facility will monitor its controls, maintaining monitoring records and specifying corrective actions to correct problems.


As seen in Food Science & Technology


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1. Evaluating the hazards. The first and most important step in managing food safety hazards is identify-ing them: one cannot minimize a hazard without being aware of it. Contamination risks are commonly found where materials are added, product is extracted, vessels are opened, raw materials are introduced, finished products are packaged or, most pernicious of all, where employees are most unlikely to follow operating procedures.

A LIMS can help food safety professionals by generating a software map of these hazard points. In addition to locations within the facility, the LIMS can also store supplier data for all incoming shipments. Using this map, the manufacturer can then use the LIMS to group data by batch, supplier, date or any other relevant parameter, allowing management to easily identify potentially contaminated or out-of-spec materials.

2. Specifying preventive steps. With food safety, prevention is always better than hazard response. This is why defining preventive measures is one of the most critical parts of a controls plan. Hazards can be introduced to the production process in many ways, including equipment failures, human error, poor envi-ronmental or site-specific conditions, as well as the use of non-conforming materials. A LIMS can play a role in preventing all of these hazards.

When a LIMS is integrated with all laboratory instrumenta-tion, it can provide automated maintenance reminders for those instruments to relevant staff members in the lab. In addition to maintenance records, detailed opera-tor competency and training records are stored so that management can verify whether staff have received the appropriate training and so that untrained personnel are

prevented from performing critical tests and procedures. This safe-guard will be particularly important if the organi-zation is audited for any reason, or has to deliver reports proving full traceability of processes and materials to a regulatory agency.

Finally, a LIMS can be used to monitor the quality of raw and process materials as they pass through quality checks during processing, helping manufacturers detect non-conforming materials as early as possible, ideally before they leave the facility.

3. Monitoring controls. The hazard points iden-tified in the first two steps require regular monitoring – as a result, they generate significant amounts of data. Using a LIMS, food safety professionals can schedule measure-ments, apply control limits, set alerts and analyze data for each control point in the facility.

Sampling plans for control points can be managed as a group, which means that producers can use a consistent protocol for each type of product moving through the facility. This capability allows management to compare data from one batch to those from another. All data generated by process monitoring is stored in a relational database and can be presented in the way that is most useful to each user, including graphs, real-time alert messages and process map overlays.

4. Maintaining records. Food safety regulations require extensive record-keeping for use in regular compli-ance audits. A LIMS greatly simplifies the process of record-keeping and retrieval by enabling entirely paperless data collection and reporting. All records stored within

the LIMS are searchable, secure and authenticated by electronic signatures and audit trails, making audits much easier by capturing and organizing all data necessary to demonstrate compliance and producing it in report formats either required or easily recognized by auditors or regulatory authorities.

5. Specifying corrective actions. When a food safety incident occurs, clearly defined corrective actions – developed in advance – must be known by all relevant staff. The records housed within a LIMS play an important role here: by analyzing the data pertaining to the affected batch, food producers can know in real time the extent of the problem and what corrective actions are required. Detailed incident reports are then stored within the system for critical review, driving continuous process improvement and streamlining any regulatory review.

ConclusionWhat all food regulation has in common is data – producers must collect, store and present massive amounts of it. This is why LIMS are now so prevalent in the food industry: proven data collection, analysis and recording capabilities can help producers monitor product quality at every step of the process, enabling them to account for full traceability of all processes and materials. From low-tech loading docks to high-tech packaging cleanrooms, a LIMS can continuously monitor an entire food production process and make demonstrating regulatory compliance much easier. More importantly, a LIMS can help ensure that the trust customers place in their food is supported by the most advanced technologies available today. •

LIMS and preventive controls plans


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SampleManager LIMS puts decision-making where it belongs – in the hands of users who can make logical choices about workflow, instrument integration and data reporting for management metrics and regulatory requirements. New workflow capabilities in SampleManager LIMS allow lab managers to easily model their processes in the LIMS – so that as your laboratory’s needs evolve, workflows can be modified to change with them.

SampleManager LIMS delivers:

• Configurable workflow and extended lifecycle features

• Simplified sample login and user-friendly search syntax

• Complete control over methods and SOPs with Lab Execution System (LES)

• Raw data storage and retrieval with Scientific Data Management System (SDMS)

• Enterprise-level Instrument Integration with Integration Manager

For more information about the benefits of SampleManager LIMS, please visit www.thermoscientific.com/SM11 or email us at [email protected]

Take Your Lab Informatics to Another Level With SampleManager LIMS

Thermo Scientific Lab Execution System Helps Scientists Go Paperless

Analytical and QA/QC labs, under ever-increasing pressure to improve time to market, ensure compliance and realize cost savings, now have an all-inclusive informatics solution that gives them complete control over their methods and standard operating procedures (SOPs) without having to purchase, integrate and validate software from multiple vendors. Trish Meek, Director of Product Strategy for Informatics at Thermo Fisher Scientific, explains how the new solution helps get scientists closer to the paperless lab.



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ISO 22000 and Integrated Informatics: Business Best Practices to Meet Global Food Safety Regulatory Challenges

In KPMG’S 2014 Food, Drink and Consumer Goods Industry Outlook Survey, 22 percent of the senior managers questioned said that “staying ahead of or

navigating changes in the regulatory environment” would consume most of their time in the coming 12 months. Nearly 20 percent said that geographic expansion would be one of the primary areas of investment in the coming months. Taken together, these two data points echo a common food industry refrain: we want to expand inter-nationally, but we’re increasingly aware of the difficulties and costs of doing so from a regulatory standpoint.

Navigating regulations and requirements on a country-by-country basis is fraught with challenges: some countries are exceptionally strict and onerous while others are developing and the regulatory framework is far from mature. So what’s the best path forward? While there’s no single formula for success, one path forward for participants in the global food supply chain is to rely on accepted international standards such as ISO 22000 as best practices for their lab operations.

Derived from the ISO 9000 family of quality management systems, ISO 22000 incorporates principles from the Hazard Analysis and Critical Control Points (HACCP) methodology and other proven food safety systems. It is widely considered the gold standard globally for food safety monitoring. In fact, the US Food Safety Modernization Act (FSMA) has modeled much of its recent requirements legislation around the ISO 22000

and HACCP guidelines. As such, ISO is an ideal starting point for companies like those in the KPMG survey that are eager to grow but that also fear “staying ahead” will consume too much of their time.

Data Management for Global ComplianceWhile some food and beverage companies still rely on manual data capture in some parts of their laboratory operations, spreadsheets and manual data transcription will prove incapable of handling the large volume of data that must be discoverable and auditable for ISO 22000 compliance – or as evidence to any other regulatory authority, such as under the European Union Regulation (EC) No. 178/2002, or US FDA Food Safety Modernization Act. Only an enterprise-level integrated informatics solution can handle the volume of data required of the latest food safety regulations in a secure and defensible manner. Laboratory Information Management Systems (LIMS) have an established track record across food and beverage laboratories for helping manage HACCP and ISO 22000 process and compliance efforts in particular. This makes a LIMS an essential part of any food or beverage company that markets and sells its products around the world.

With a LIMS managing workflow and process, and serving as the central source of data for all sample testing, from raw materials through to the final packaged product, food and beverage companies can be assured that the data

By Trish Meek, Thermo Fisher Scientific As seen in Lab Manager


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will be defensible to regulatory authorities, management will have the data necessary to routinely reduce the risk of contamination or to effectively manage a food recall if that should prove necessary. Most important, the money invested in building the brand will be secured and the consuming public will continue to have confidence in the quality and safety of the food products being sold. The adherence to regulatory requirements is one very important part of the ongoing efforts to build and support a brand. If processes are not in place to capture non-conforming product before it reaches the public, then a recall is a very real possibility and one which is badly managed or widespread will have dramatic impact on the value of the brand and shareholder confidence. HACCP guidelines can introduce another layer of data management, with five critical steps in the process (Hazard Evaluation, Defining

Preventive Steps, Establishing Monitoring Controls, Maintaining Monitoring Records, and Specifying Corrective Actions) each adding their own level of complexity to the lab’s data management challenges, but ultimately improving the consumer trust in the brand.

Enterprise-Level Integrated Informatics—Built-In Best PracticesFor food producers, the main benefit of using LIMS to manage ISO 22000 compliance is its ability to address compliance needs in multiple geographies – meaning both “everywhere in the world” and “at every step of a process.” In the sense of “everywhere in the world,” a standard ISO/LIMS strategy can be implemented in any country without sacrificing regulatory rigor or compliance. At the individual process level, “global” means that a LIMS collects and manages data over the entire life cycle of a food product, from incoming ingredient deliveries to finished product shipments (and all HACCP points in between).

No matter how many laboratories are involved in a company’s manufacturing processes, or where in the world they may be, the LIMS is capable of managing the levels of relationship complexity and connectivity with multiple sites and manufacturing environments. Enterprise-level LIMS can build all the ISO 22000 and HACCP steps into their workflow structure so that adherence to these regula-tions are routine not only in the lab but across the entire organization.

ConclusionRegulations are increasing every day and in every region of the world now. With our global food culture, we want to experience what the world has to offer and it is impera-tive that no matter where we live, and no matter where our food comes from, we can be assured that our food is safe from contaminants or impurities of any kind. An enterprise-level integrated informatics solution makes this possible. In fact, choosing to comply with a standard as comprehensive as ISO 22000 is actually a smart decision for global players in the food industry. Following ISO 22000 and HACCP guidelines is a business best practice which guarantees that processes and quality parameters meet even the most onerous requirements. The LIMS eliminates burden by automating compliance and leaves only the benefits: increased efficiency, improved product safety and reduced, well managed recalls.


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Using Your Laboratory to Protect Your Brand

Summary The food supply chain has become a complex global system consisting of small to large domestic and for-eign manufacturers, processors, packers, distributors, and transporters with few common business practices. Consumers now expect year-round supplies of fresh fruits and vegetables as well as more exotic foods. This has increased the risk of a major food safety incident. Compliance with differing government regulations and enforcement policies adds to the complexity. With such a convoluted value chain with multifaceted reporting requirements, how can consumer-facing suppliers dem-onstrate regulatory compliance and protect their brands? Laboratory technology can play a key role in brand protection by efficiently managing test samples. Laboratory Information Management System (LIMS) facilitate end- to-end traceability of samples and products and all associated laboratory processes; providing a central repository for data and test results for increased traceability and regulatory compliance.

What’s at Risk? While consumer brand preference is subjective, product safety is not. The implied contract between producer and consumer is that products are unadulterated and will not cause harm. According to the Grocery Manufacturers Association (GMA), the voice of the consumer packaged goods industry in the US, ensuring product safety is the industry’s single most important goal. While this may be true, for producers, brand protection is also critical. Recall costs can range from tens to hundreds of millions of dollars and lost sales due to damage to the brand can be devastating.

The Peanut Corporation of America (PCA)—a supplier of peanuts, peanut butter, peanut meal, and peanut paste—provides a case in point. In 2008, the US FDA determined that one of the company’s processing facilities was the source of the worst salmonella outbreak in US history, killing nine and sickening hundreds. Not only was PCA forced into bankruptcy, sources estimate the cost of the incident to the peanut industry at $1 billion in lost product and sales. The domino effect throughout the food industry involved the recall of about 1,000 different products. This single incident wreaked havoc with not just one company, but an entire industry.

The cornerstone of the Food Safety Modernization Act is prevention. This will require facilities to place greater emphasis on traceability, creating urgency for them to take the lab to the field and deploy laboratory information management systems.

By Paula Hollywood ARC Advisory Group


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This incident alone demonstrates the expression that “an ounce of prevention is worth a pound of cure.” In other words, it is far better to avoid problems in the first place than to have to fix them later. Experts cite the PCA incident as the impetus behind the Food Safety Modern-ization Act (FSMA).

FSMA Emphasizes Prevention The cornerstone of the FSMA is to prevent incidents based upon risk assessment, as opposed to rapid response to an incident. The Act will require facilities to write, implement, document, and demonstrate a food safety plan. It will likely require facilities to go deeper into the supply chain than the current “one up and one down” regulations. This deeper penetration of the food chain will impact several hundred thousand foreign and domestic facilities registered with the FDA.

For food processors, more stringent controls will be required, enabling a more proactive approach to quality. At minimum, preventive controls will require new practices with more control points and additional requirements for Corrective Action and Preventive Action (CAPA), root cause analysis, and more continuous documentation. Producers must also demonstrate crisis management preparedness, product traceability, batch coding, and Hazard Analysis and Critical Control Points (HACCP) plans. To improve effectiveness, these systems must interact with many applications throughout manufacturing and its supply chains such that the information can be quickly accessed to contain the scope of a recall in the event of an incident. Plans will differ from facility to facility based upon the level of risk to food safety.

Taking Lab Technology to the Field Globalization of the food supply chain has not only increased the availability of more exotic foods, it has also increased the number of pathogens. The FDA has reported that there are five times more identified pathogens today than 50 years ago. Traceability of each product from raw material through production and packaging dictates that more pervasive use of laboratory technology in the field will be necessary.

To minimize risk, food processors must be able to produce detailed and accurate records that identify the quality, quantity, disposition, and handling of products at each handover point. Raw material testing and identity verification at each handover point are critical to trace-ability and quality management. Portable optical analysis tools, such as those available from Thermo Scientific, bring the laboratory to the field for fast, accurate mate-rial identity verification. Handheld Raman, NIR, and FTIR spectrometers can help users quickly verify raw material identification to determine suitability for further process-ing. These handheld devices require little to no sample preparation, enabling technologies previously restricted to laboratory use to be used in the field to speed raw mate-rial identification and data synchronization. The ability to locate the source of a problem through good traceability can minimize the time to recover and avoid extensive damage to the brand and company reputation.

Major Elements of the FSMA Food Safety Plan Prerequisite programs are in place to ensure food is produced in a safe and sanitary manner

Hazard analysis that identifies all potential risks throughout processing

Preventive controls that are implemented to mitigate risks

Monitoring of preventive controls to ensure they are properly implemented

Verification that the preventive controls have the intended reduction in risk

Re-analysis of the hazards and preventive controls when there are significant changes in the process or every three years


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LIMS Secures the Data Environment The increased traceability requirements mandated by FSMA not only require greater amounts of data, but also require turning that data into useful information. A laboratory information management system, like Thermo Scientific SampleManager LIMS™, can manage samples, act as a repository for records data and test results, and provide increased traceability and full chain of custody to help ensure regulatory compliance. For producers, a LIMS can help verify that product quality meets regulatory stan-dards while recording that data for subsequent inspec-tions, if required. For auditors, a LIMS facilitates review of compliance reports and related certificates of inspection stored with the LIMS to verify safety. Integrating LIMS with enterprise systems such as ERP, PIMS and MES enables organizations to share information throughout the enter-prise for faster and improved decision making.

FSMA increases the stakes to the point where home-grown systems and paper-based tracking methods could place food producers and processes at greater risk for non-compliance, which in turn could jeopardize not only the brand, but the entire operation. Commercial LIMS such as Thermo Scientific SampleManager™ LIMS that are specifically designed to help organizations comply with regulations such as GMP, GLP, HACCP, CO-DEX, and 21CFR Part 11 are likely to prove indispensable under the FSMA, since they provide a secure audit trail and document corrective actions. While the emphasis is on prevention, the ability to quickly react to a contamination incident minimizes recall costs and potentially protects brand reputation.

Conclusion The current food supply chain not only increases con-sumer access to year round supplies of fruits and veg-etables, it also increases the number of pathogens that could cause contamination. The FSMA requires tools that focus on prevention and provide a framework for regula-tory compliance. LIMS provides a secure environment for monitoring batch relationships between raw materials, processed materials, and packaged goods in the complex food supply chain. As the centralized system for collecting, storing, processing, and reporting all food lab-generated data, LIMS provides a complete overview of product quality in accordance with regulatory requirements. •

For more information about Thermo Scientific Integrated Informatics

solutions for the food and beverage industry, visit our Traceability

website, visit www.thermoscientific.com/SM11 or contact us at

[email protected]


www.thermoscientific.com/traceability


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How to Transform Your Lab and Business

In many industries, from pharmaceuticals to food, busi-ness agility is dependent on a well-funded, efficient and prolific R&D function. Successful companies tirelessly monitor performance and quality, and are psychologically and structurally ready to capitalize on every new opportu-nity to transform and grow. These successful enterprises have discovered that four drivers are critical to sustained business transformation: business intelligence, innova-tion, automation and integration. When all four drivers are in sync, business transformation isn’t just a strategy anymore, it’s a state of being.

For those businesses unfamiliar to the four drivers, all is not lost. In fact, many established businesses are closer than they think to transformation because they’ve spent more than two decades methodically adding technology in the business version of “keeping up with the Joneses”. But all this investment will be for naught unless corpora-tions strategically align non-integrated, often disparate technology and resources in ways that enable maximum agility, and there’s no better place to start realignment than with research and development.

Drivers of transformationThe pull of technology is a constant when advancing your business. And for a R&D laboratory of any size, new tech-nologies go well beyond analytical instrument advance-ments alone. Yes, technology is an enabling catalyst that can accelerate transformation, but it can also distract by putting constant pressure on laboratories and their man-agement to stay ahead.

Technology is simply a means to an end: data. Data is the true currency of business, especially in the laboratory, and business transformation is unsurprisingly linked to effective data management. Even with the best laboratory instruments and information technology infrastructure in place, there may be little difference between one point solution and another. It is how the data is used across the enterprise to enable business intelligence and decision making that becomes the distinct competitive advantage.

A flexible data management solution, such as a Laboratory Information Management System (LIMS), is designed to enable business intelligence and decision making. A LIMS is an invaluable tool that can be configured and integrated

to transform any organization, allowing activities, both inside and outside the enterprise environment, to be automated and monitored for greater efficiency, produc-tivity and data integrity.

Because LIMS are so tightly integrated with other enter-prise operation systems, insights from a LIMS-enabled R&D laboratory are infinitely more important to businesses seeking true enterprise-wide agility than previously real-ized. Enterprises aren’t only capturing and collecting data; they are making data actionable, positioning management to transform their companies into nimble enterprises capable of responding quickly to new regulations or market trends and flexible enough to know and capitalize on cost-saving or margin-growing opportunities in the future.

Implementing the four pillarsTo be business transformation ready, a company must rely on a platform that is reinforced by four pillars: business intel-ligence, innovation, automation and integration. The good news is that many R&D functions have already invested in some aspects of these pillars, so implementation is less burdensome than many realize.

The biggest challenges many elite enterprises face are actually external forces completely out of their control, from geopolitical and economic macro trends to global threats to health and the environment. This lack of control creates a tumultuous global business climate that conspires to unravel even the most well-thought-out strategic plans. Businesses can no longer adopt a wait-and-see approach. To have any chance of sustained success, today’s enterprises must be more agile and aggressive than ever.

By Kim Shah, Thermo Fisher Scientific

As seen in R&D Magazine


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Business Intelligence (BI)Many organizations declare success once they’ve acquired the ability to quickly and efficiently collect, store and organize knowledge. To be truly business transforma-tion ready, however, companies must use BI to do more than organize; they must insist on action. In many enter-prises, if a manager or executive wants to see laboratory progress or productivity reports, for example, the IT department has to step in. This extra step discourages many executives from taking advantage of the rich data that surrounds them. Thanks to more mature BI approaches enabled by cloud computing, however, laboratory personnel can now create real-time dashboard reports that manag-ers and executives can access continuously via desktop, tablet or mobile device. They are a few clicks away from being able to make a decision. Analytical data, so critical for quality assurance, consistency and compliance, is now more useful today and it can be used to drive profitable product innovation in the future.

InnovationInnovation is tightly aligned with information. A labora-tory driven by data insight—not just instrumentation—is able to discover avenues for innovation that exist only in a macro view. From improved food or drug quality, for example, to more efficient ways to manufacture consumer products or oil and gas, liberating laboratory data in dashboard form turns it into a catalyst for continuous change. And the ability to recognize and exploit pathways for innovation is as much cultural as it is process-oriented. When employees become accustomed to seeing a bigger picture—through data—business transformation becomes a cultural norm, not a discrete initiative.

AutomationTime is an ally of discovery. When staff can devote more of it to innovation, great things happen. Automating time-consuming tasks, such as instrument calibration, compliance, reporting, user training and maintenance, liberates more time for new ideas and improved decision making, investing this

perishable intellectual capital back into business transforma-tion. As businesses turn to new markets and just-in-time product innovation to compete, the ability to automate processes will become one of the most important charac-teristics of a business transformation-ready company.

IntegrationWhen people, processes, technology and data are stuck in silos, business agility is impossible. From laboratory instruments to software systems and mobile devices, nothing in an enterprise should exist in isolation, unable to inform decision making and support rapid business transformation. From tracking raw material shipments at the loading dock to assimilating data from different laboratory instruments, true visibility—to inform business decisions—is only possible when an executive dashboard is built from comprehensive, near real-time data in open digital formats.

A plan now exists for constructing an enterprise transfor-mation-ready R&D department. When data is presented to decision makers logically and intuitively, it fuels new strategic growth, and it does so with unprecedented ease. Step one is liberating hidden insights that are stored in laboratories around the world, enabling more smart people to proactively query and use vast stores of knowledge. When that happens, R&D is truly transformed, its laboratory is a growth driver, management is fully engaged and the entire business couldn’t be happier. •

By automating the laboratory and bridging

islands of data, laboratories gain time and cost

savings, as well as access to real-time informa-

tion that can be used across the enterprise.


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Traceability is Key in Food Safety: Europe Leads the Way

What makes Europe’s success so remarkable is how complex the system is: Despite strict regulations enforced to protect more than 500 million people, compliance takes place without interfering with the independence of the EU’s 27 sovereign nations. Such a structure would be impossible without a massive technology infrastruc-ture and investment in state-of-the-art data management technologies, including laboratory information manage-ment systems (LIMS), which are widely used by industry and governments to structure laboratory sampling, analysis and reporting tasks, and integrate food quality data across vast enterprise systems.

What Makes Europe Different?Europe hasn’t always been the world standard for food safety. Several food crises, including outbreaks of mad cow disease (formally known as bovine spongiform encephalopathy or BSE), salmonella and botulism, led to the establishment of the European Food Safety Authority (EFSA) in 2002. The organization’s mission is straightfor-ward, but ambitious: “to deliver independent, high-quality and timely scientific advice on risks in the food chain from farm to fork in an integrated manner and to communicate on those risks in an open manner to all interested parties and the public at large.”

If achieving this goal wasn’t challenging enough, EFSA must do all this while respecting the sovereignty of the EU’s member states. The dramatic rise in international

trade over the last 20 years, coupled with increasingly complex supply chains in food manufacturing, means that new rules must be all-encompassing without being stifling. While Europe needed stricter regulations in 2002, EFSA had to promulgate them in concert with the food safety authorities of individual nations within the EU.

The same law that established EFSA – Regulation EC/178/2002 – laid the groundwork for implementation guidelines, principles and procedures. For example, any food produced in Europe or imported is now subject to some of the strictest traceability requirements in the world. The regulation requires that manufacturers and distributers have “the ability to trace and follow food, feed, and ingredients through all stages of production, processing and distribution.”

To date, EFSA’s massive undertaking is working. The organization cooperates with more than 400 organiza-tions within the EU to carry out food testing, and since 2002, EFSA has published more than 2,500 “scientific outputs”—pieces of research used to institute new regulations or modify existing rules. The number of cases of BSE has fallen from thousands each year before the institution of EFSA to only 44 in 2010, and now only two percent of EU residents consider mad cow to be a possible food risk. Salmonella contamination has fallen off even more dramatically, decreasing by 50 percent from 2004 to 2009.


As seen in Food Safety Magazine

For more than a decade, European authorities and producers have been held to higher standards for food quality than any other region worldwide, and the results have matched the regulation: Europe has one of the lowest levels of food contamination in the world.


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One of the key contributors to successful monitoring of food safety “from farm to fork” is the application of consistent practices to the laboratory environment. Since 2010, EFSA has required that laboratories generating data that will be used as a part of any traceability record must be accredited under the ISO/IEC Standard 17025, which demands that labs keep records not just of the samples tested and their results, but of supporting data such as instrument calibration status, staff training records, reagents and standards, etc. Having this universal accredi-tation requirement for all food-related analysis means that it is possible to compare data sets from different sources, which in turn leads to faster and more accurate monitoring of food-related incidents that may impact EU citizens.

LIMS Plays a Starring RoleAs well thought-out as the EFSA approach is, the system would be impossible to administer without sophisticated data management, like today’s enterprise-level LIMS. From 400 independent organizations, individual manufac-turers and national authorities within the member states to the EFSA itself, the massive sampling operation hinges on consistent, reliable laboratory testing, management

and integration. LIMS monitor instrument calibration and maintenance schedules, ensure proper training records for personnel, manage workflow and testing requirements inside labs and store all records related to sample testing and report generation. A LIMS also provides a secure data management environment for monitoring batch rela-tionships between raw materials, processed materials and packaged goods in an increasingly complex food supply chain. Having a LIMS also ensures that the external accreditation program for ISO 17025 is significantly less burdensome for the laboratory by having online search-able access to supporting records—something that is both time consuming and tricky if the data is kept as paper records.

Across many individual labs, LIMS aggregate and analyze the massive data sets from throughout Europe, helping authorities identify potential outbreaks before they happen. Consider the Department of Agriculture in Ireland, where agrifood remains one of the country’s most important industries, accounting directly for more than eight percent of both GDP and employment and exports of more than €8.1 billion.

These Irish Department of Agriculture’s duties require timely and accurate flow of information and research results across all locations, and the Irish Department of Agriculture uses Thermo Scientific LIMS to ensure accura-cy and gather new epidemiological insights. The solution allows for improved sample tracking through automated label generation and electronic transfer of data to third parties, including European authorities. The ability of the LIMS to retrieve, analyze and report data – with speed and efficiency impossible in a paper-based system—also

allows authorities to use the system as a database for animal disease surveillance. This information is ultimately compiled with data from across Europe to model poten-tial trends and prevent contamination issues before they become serious.

ConclusionAnticipating the steps needed to fully comply with the Food Safety Modernization Act, leading food and beverage brands can look to experience in Europe for guidance. After all, many manufacturers globally are already comply-ing with the strictest food testing regulations in the world because they’re distributing in Europe. And while Europe’s regulations are indeed stringent—from traceability to handling and so much more—they are also best practices that help food companies protect their brand reputations by offering a product that is uniform in quality, safety and taste every time.

Adopting best practices and achieving compliance isn’t simple, but it’s far easier today thanks to the advancing technology of today’s LIMS. Navigating and thriving in a system as complex as EFSA’s requires more than instinct and hands-on experience. With LIMS behind the scenes automating data aggregation and analysis, equipment calibration and maintenance, technician training and more, the global players in the food supply chain are united in a common goal: ensuring that everything we eat and drink is tasty, nutritious and, most importantly, safe. •Colin Thurston is Project Director, Informatics, at Thermo Fisher Scientific.


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Profile Molkerei Alois Müller (UK) is a market leader in European dairy products. The Müller UK site specializes in yogurt products; from low-fat yogurt offerings to yogurt and cereal combinations.

Müller UK sales have been increasing annually since the company entered the UK market due to a focus on quality and innovation. In fact, the state-of-the-art production facility at Market Drayton that was opened in 1992, has been significantly expanded several times to add more manufacturing, warehouse and distribution capability. Now, Müller produces more than a third of all yogurt eaten in the UK from the Market Drayton factory.

Focus on Quality Control The Müller UK labs are mainly focused on production QC. “But we test product from the start,” Shaheen Adatia, Müller UK’s Laboratory Manager explains. “Milk from farms arrives by tanker and is passed by pumps into silos, then separated into skim milk and cream, and some skim into concentrate. Yogurt mixes are made in tanks and batch sterilized. If the batch meets specifications, it is processed through a heat exchanger, cooled, and placed in an incubation tank where culture is added. Every step in the process undergoes quality checks. During incubation, the pH is monitored and checked every two hours. After eight to nine hours of incubation, the pH has dropped and a final pH check is made when the yogurt is cooled.”

With the checks being performed and recorded manually, there were many places a LIMS could be used to automate and expedite the QC tasks.

Efficiency Expectations The decision to implement a LIMS was driven by the increase in production demand, and justified by the need to increase the lab’s efficiency. Müller UK’s paper-based system for tracking and reporting QC data was supple-mented by Microsoft’s Excel spreadsheet program. A LIMS would dramatically reduce the amount of error-prone paperwork and expedite testing.

The LIMS was also expected to assist significantly in real-time monitoring of Müller’s production processes and play a pivotal role in ensuring quality control for finished product. By using a LIMS, Müller would be able to trend all data and make decisions and necessary improvements much faster.

LIMS Selection

Müller UK selected Thermo Scientific LIMS to manage QC data for raw materials, in process, and finished dairy desserts. One of the reasons Müller selected the LIMS was that it could map easily to their business processes via the LIMS’ Workflow functionality. The ease of imple-mentation was also attractive and drove the decision to implement and configure the solution without any significant help from Thermo Fisher.

Integrating the LIMS with as many pieces of the lab equipment as possible allows for automated data transfer and additional efficiencies.

Customer Case Study:

Thermo Scientific LIMS HelpsMüller’s Yogurt Productionat UK Quality Control Laboratory

Making the transition from a manual system that’s essentially paper-based to one which automates almost every quality control (QC) sample check and reporting process is a major undertaking for any company. With UK production over 1.8 billion pots of yogurt per year, the time was ripe for change at Müller and Thermo Fisher Scientific was the clear solutions provider.


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“The work processes were reviewed and the LIMS team asked, “What are we doing?”, “Why are we doing it?”, and “Can it be done better?” Adatia recalls. “From November to May, methods and workflows were input, systems were set up, and the layout of the lab and equipment reorganized to streamline operations.”

Workflows for milk reception, separation and pasteuri-zation were developed, along with workflows for other products and areas of manufacture.

The milk reception processes managed by the LIMS were developed to include barcoding samples from the tankers upon receipt, checking the milk for antibiotics, and checking the milk composition for fats, protein, lactose, and solids. Any out-of-specification parameters can be reported automatically. For instance, if a tank fails antibiotics, it gets rejected outright, the LIMS flags the result as being out-of-spec and creates a report automatically.

IT Involvement Müller UK’s Information Technology (IT) team was actively involved in the LIMS selection and implementation, and worked closely with the lab team to select and implement the LIMS. In fact, there’s a dedicated IT person to ensure the integrity of the solution.

IT reviewed distribution of all the QC information, people were asked what they wanted, and then they were provided with the appropriate reports.

With the LIMS, IT determined the access privileges to the data, which included sample reports, daily averages, and moving averages. These are all read-only and certain reports such as sales are restricted to a for-your-eyes-only status that can only be accessed by certain levels with authority to do so.

The reports are more accurate and stay consistent within the system. Interfaces to various instruments and lots now ensure that there are no input or copying errors.

The Importance of Training The implementation team had to overcome training per-sonnel on the new system. The majority of people were only used to the paper-based system of recording results.

Basic PC training was arranged at the very start for every-body. This was followed by an introduction to the LIMS, and training on the first workflow.

“A one month transition was scheduled to test the LIMS and ensure that everyone used it correctly,” Adatia states.

“Then, once we were comfortable with using the system, the system went live.”

After the implementation of a couple of workflows, workshops were held so that everybody could further explore the system and ask questions in a more informal atmosphere. This proved to be a valuable tool in the implementation of the system.

Summary Implementing a Thermo Scientific LIMS has helped Müller UK’s lab to not only meet production demands with equa-nimity but will also position them to meet future challenges.

At the time of the LIMS installation, incoming and outgo-ing milk products, storage silos and separator workflows were tracked by the LIMS, however a lot of product had yet to be incorporated. The goal for future phases of this installation is to enable automatic release of finished product.

“The LIMS is ideal as its flexibility allows us to expand and develop the services provided by the Laboratory,” he continues. “The LIMS also enables us to do more with the data, such as create trend analyses.”

Adatia also anticipates changes down the line with the roll out of corporate-wide solutions. In addition, the LIMS has the potential for integration with other business systems. With a Thermo Scientific LIMS in place, the lab is confident that they can meet these and other challenges.


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Integrated Informatics Solutions Built for Industry Today’s data management challenges are more complex than ever. Laboratories worldwide seeking a single, integrated informatics platform can now standardize on one comprehensive laboratory information management system, encompassing LIMS, LES and SDMS functionality. You can rely on our Integrated Informatics solutions to deliver the flexibility you need to meet changing regulatory requirements and your business objectives. Built with workflow and dashboard driven technology and enterprise integration tools, our Integrated Informatics Solutions will reduce your total cost of ownership and deliver a faster return on your Informatics investment. Thermo Scientific Informatics solutions are relied on at food and beverage companies around the world. To support our customers, we provide implementation, validation, training, maintenance and support with the industry’s largest worldwide Informatics services network. •

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T hermo Fisher Scientific has been providing state-of-the-art and enterprise level Informatics solutions for more than 30 years. We are proud to count amongst our portfolio some of the largest global organizations across every industry, including

the broadest range of complex customer requirements related to integrated, enterprise-level informatics solutions. Our comprehensive Informatics solutions are designed to deliver full laboratory functionality for method execution, laboratory and data management on one proven platform – LIMS, LES, SDMS, in addition to full integration with CDS and other laboratory instrumentation.

As an organization, Thermo Fisher Scientific is committed to providing comprehensive enterprise-level informatics solutions that encompass ISO 9001-certified quality soft-ware, implementation, training, and ongoing technical support. Our Quality Management System (QMS) is registered and certified by ISO 9001 requirements, and includes all of our software development locations around the world. This ISO registration covers our Quality Management System for the design, development, sales, implementation and support of all our computer based laboratory information automation systems.

The global scale and comprehensiveness of the continuous ISO certification of our Quality Management System is unique in the industry. Across the full range of life sciences, from bioanalytical labs, to R&D, pharmaceutical manufacturing and QA/QC labs, Thermo Scientific Integrated Laboratory Informatics are helping our customers meet their laboratory and business goals.




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